Galexos

The recommended dose of simeprevir is 150 mg taken once daily with food. The capsule should be swallowed whole with fluids and not crushed or chewed. Ideally, simeprevir should be taken at the same time each day.

Simeprevir must be taken in combination with other anti-viral medications. It is usually taken for 12 or 24 weeks, depending on your situation. The effectiveness of the combination of medications is determined by your doctor with blood tests.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Galexos be taken exactly as prescribed by your doctor and not reduced. Reducing the dose may cause the medication to fail. If you miss a dose, and it is within 12 hours of the missed dose, take it as soon as possible with food and continue with your regular schedule. If it is more than 12 hours past the time of your missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Galexos at room temperature in its original package, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each white capsule, marked with "TMC435 150" in black ink contains 154.4 mg of simeprevir sodium salt, which is equivalent to 150 mg of simeprevir. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate and sodium lauryl sulphate; capsule: gelatin and titanium dioxide (E171); ink: iron oxide black (E172) and shellac (E904).

Do not take simeprevir if you:

• are allergic to simeprevir or any ingredients of the medication
• cannot take sofosbuvir, peginterferon alfa or ribavirin
• are pregnant or plan to become pregnant

There may be an interaction between simeprevir and any of the following:

• Abiraterone
• Aliskiren
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• Amiodarone
• anticancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apixaban
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• Bicalutamide
• Bosentan
• Bromocriptine
• Buprenorphine
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carvedilol
• cetirizine
• chloroquine
• Cimetidine
• ciprofloxacin
• Cobicistat
• Colchicine
• conivaptan
• Cyclosporine
• dabigatran
• Dabrafenib
• Dantrolene
• Dapsone
• Deferasirox
• Desvenlafaxine
• Dexamethasone
• Digoxin
• Disopyramide
• Domperidone
• Dronedarone
• Edoxaban
• Eltrombopag
• Enzalutamide
• ergot-containing medications (e.g., Dihydroergotamine, ergotamine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Flutamide
• Gemfibrozil
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Hydrocortisone
• ivermectin
• lidocaine
• Loperamide
• Losartan
• lumacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• Methadone
• mifepristone
• milk thistle
• Mirtazapine
• Modafinil
• Nadolol
• nefazodone
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Norfloxacin
• Ondansetron
• Oxycodone
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• praziquantel
• Primaquine
• protein kinase inhibitors (e.g., Crizotinib, Dasatinib, imatinib, Nilotinib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• Prucalopride
• quinidine
• quinine
• Ranitidine
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• Rivaroxaban
• Romidepsin
• St. John's wort
• seizure medications (e.g., Carbamazepine, Gabapentin, Levetiracetam, Phenytoin, primidone)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• siltuximab
• Sirolimus
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus
• tenofovir
• Teriflunomide
• Ticagrelor
• Ticlopidine
• Tocilizumab
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Venlafaxine
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Galexos. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Galexos.

HEALTH CANADA ADVISORY

December 1, 2016

Health Canada has issued new restrictions concerning the use of Galexos® (simeprevir). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Birth control: The effect of simeprevir on the development of an unborn baby has not been studied, however it is often taken with medications that can cause severe birth defects to an unborn child. Both partners should use a reliable form of birth control while taking Galexos and for 6 months afterwards (the time it takes for ribavirin to be cleared from the body).

For women, your doctor will not give you simeprevir until you have had a negative pregnancy test. Your doctor should have you continue to do monthly pregnancy tests to ensure that you do not become pregnant while using Galexos.

Methods of birth control that use hormones, such as a birth control pill, patch, or injection, may not be fully reliable as simeprevir interacts with many medications and may change the way that your body uses the hormones. At least 2 forms of non-hormonal birth control (condom, diaphragm) must be used while you are taking Galexos.

Hepatitis B Reactivation: If you have had hepatitis B infection in the past, taking simeprevir may cause the hepatitis B to reactivate. This can cause liver damage, possible leading to the liver failure or death. Talk to your doctor if you have a history of hepatitis B infection.

Hepatitis C virus response: Only genotype 1 and genotype 4 hepatitis C virus strains have been studied and determined to respond to simeprevir. The safety and effectiveness of using simeprevir to treat other strains of hepatitis C virus have not been determined.

Infection with Human Immunodeficiency Virus (HIV): The safety and effectiveness of treatment with simeprevir have not been established for people who also have human immunodeficiency virus (HIV).

Lactose intolerance: Galexos contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Galexos. Talk to your doctor about other alternatives.

Liver function: Simeprevir is not recommended for people with active, worsening liver disease, or moderately-to-severely reduced liver function. If you have a history of reduced liver function, discuss with your doctor how Galexos may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Galexos, and whether any special monitoring is needed.

Organ transplantation: The safety and effectiveness of treatment with simeprevir have not been established for people with liver or other organ transplants. Simeprevir may interact with medications used to prevent rejection of the transplanted organ.

Skin reactions: Simeprevir may cause skin rash or itchiness with or without a rash. It may also make your skin more sensitive to ultraviolet light from the sun or tanning beds. While you are taking simeprevir, avoid unnecessary exposure to sunlight. If you notice any unusual skin rash or peeling, contact your doctor.

Pregnancy: Simeprevir has not been studied for use by pregnant women and it must be taken with other antiviral medications, some of which have been shown to cause serious harm to the developing baby. Tell your doctor immediately if you become pregnant while using Galexos.

Breast-feeding: It is not known if simeprevir passes into breast milk. If you are a breast-feeding mother and are taking Galexos, it may affect your baby. Breast-feeding should be stopped before starting treatment with simeprevir.

Children: The safety and effectiveness of using Galexos have not been established for children.